ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate ANX-530 (vinorelbine injectable emulsion).
"I congratulate our development team for achieving this important milestone on schedule in December, as planned. ANX-530 has the potential to offer important benefits to cancer patients, and we look forward to working with FDA towards its approval," said Brian M. Culley, Principal Executive Officer of ADVENTRX. "The ANX-530 NDA submission is a key step in our strategy to create valuable products that improve the performance of currently approved drugs."
The Company is seeking approval of ANX-530 for the same indications as Navelbine®, a branded formulation of vinorelbine, including non-small cell lung cancer. ADVENTRX submitted the NDA as a 505(b)(2) application, which relies in part on the FDA's findings of safety and effectiveness of a reference drug. The Company's 505(b)(2) NDA submission includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of ANX 530 and Navelbine, the reference drug.
ANX-530 is ADVENTRX's proprietary emulsion formulation of vinorelbine. Vinorelbine is a vesicant and venous irritant, and these adverse effects can limit its tolerability. ANX-530 was designed to be bioequivalent to the reference drug while reducing the incidence and severity of vein irritation associated with intravenous delivery of the drug. In a clinical bioequivalence study, ANX 530 and the reference drug were determined to be bioequivalent.
ADVENTRX acquired ANX-530 in 2006 and retains exclusive worldwide rights to ANX-530, other than in China, Hong Kong, Macau and Taiwan.
SOURCE ADVENTRX Pharmaceuticals, Inc.